Inspection Capabilities: Visual inspection: - Presence of Foreign Particulate Matters, - Cosmetic Defects,- False Fill Level and Product Color.
Computer-based automated measurement system: image acquisition, processing, and decision making.
High resolution cameras coupled with illuminators automatically positioned so to magnify regions of interest and designed according to defect type.
Maximum accessibility of electrical and mechanical component for easy maintenance.
Connections to Active Directory and VPN router for machine remote access.
Validation package guarantees complete and efficient regulatory compliance.
Full batch control testing: fast, reliable and repeatable.
Testing of all nominal production line speed.
MES (Manufacturing Execution System connection) allows remote machine data exchange & download
Real time display of statistical raw data
Easy, quick and safe remote access
It is an automated camera based measurement technology detecting visual defects, such as:
Presence of Foreign Particulate Matters
False Fill Level and Product Color
For each inspected container, a collection of images is acquired using high resolution video cameras under designed illumination conditions. Defects on the package are identified and/or measured by dedicated image processing algorithms and the package is classified as conforming or non-conforming with given standards.
Equipment test method refers to:
United States Pharmacopeia:
USP General Chapter <1>: “Injections”
USP Gen. Chap. <790>: “Visible Particulates In Injections”
USP Gen. Chap. <1790>: “Visual Inspection of Injections”
European Pharmacopeia § 2.9.20:
“Particulate Contamination: Visible Particles”
Machines Qualification and Validation requirements stated in EU Annex 15
All computerized systems are designed according to ISPE GAMP 5 guidelines and to comply with FDA 21 CFR Part 11 and EU Annex 11